Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,584, 14 ta’ Mejju, 2004 pptx

B 4661 L.N. 273 of 2004 PLANT QUARANTINE ACT, 2001 (ACT NO. XVIII OF 2001) Forest Reproductive Material Regulations, 2004 IN exercise of the powers conferred by article 32 of the Plant Quarantine Act, 2001, the Minister for Rural Affairs and the Environment has made the following regulations:- 1. (1) The title of these regulations is the Forest Reproductive Material Regulations, 2004. (2) These regulations shall come in force on the 15th May, 2004. 2. (1) The scope of these regulations is to make provisions for assuring that any forest reproductive material produced, placed on the market in Malta or being transhipped through Malta prior to its transport to another Member State meets specified standards of quality. (2) These regulations shall apply to the production with a view to marketing and to the marketing of forest reproductive material within the European Union of the genera and species and artificial hybrids listed in Schedule I of these regulations. (3) These regulations shall not apply to forest reproductive material: (a) in the form of planting stock or parts of plants intended to be used for purposes other than forestry, or (b) intended to be exported or re-exported to third countries. 3. For the purpose of these regulations, the following definitions shall apply: “the Act” means the Plant Quarantine Act, 2001; “autochthonous” and “indigenous” refer to either of the following: Title and commencement. Scope. Interpretation. Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,584, 14 ta’ Mejju, 2004 Taqsima B –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– B 4662 (a) “autochthonous stand” or “seed source” which refers to one that normally has been continuously regenerated by natural regeneration. The stand or seed source may be regenerated artificially from reproductive material collected in the same stand or seed source or, autochthonous stands or seed sources within close proximity; and (b) “indigenous stand” or “seed source” which may be an autochthonous stand or seed source or, is a stand or seed source raised artificially from seeds, the origin of which is situated in the same region of provenance; “basic material” refers to any of the following: (a) “clone” being a group of individuals (ramets) derived originally from a single individual (ortet) by vegetative propagation, for example by cuttings, micropropagation, grafts, layers or divisions; (b) “clonal mixture” being a mixture of identified clones in defined proportions; (c) “parents of a family” which are trees used to obtain progeny by controlled or open-pollination of one identified parent used as a female, with the pollen of one parent (full- sibling) or a number of identified or unidentified parents (half- sibling); (d) “seed orchard” being a plantation of selected clones or families which is isolated or managed so as to avoid or reduce pollination from outside sources, and managed to produce frequent, abundant and easily harvested crops of seed; (e) “seed source” consisting of trees within an area from which seeds are collected; (f) “stand” being a delineated population of trees possessing sufficient uniformity in composition; “the Department” means the department responsible for plant health; “the Director” means the Director responsible for the Department and includes to the extent of the authority given, any officer authorised by him, in writing, to act in that behalf for any of the purposes of the Act; B 4663 “forest reproductive material” is reproductive material of those tree species and artificial hybrids thereof which are important for forestry purposes in all or part of Malta and in particular those that are listed in Schedule I of these regulations in such manner that categories of forest reproductive material may be: - (a) “qualified” referring to reproductive material derived from basic material that can be seed orchards, parents of families, clones or clonal mixtures, the components of which have been phenotypically selected at individual level and which meets the requirements set out in Schedule V. Testing need not necessarily have been undertaken or completed; (b) “selected” referring to reproductive material derived from basic material which shall be a stand located within a single region of provenance, which has been phenotypically selected at the population level and which meets the requirements set out in Schedule IV; (c) “source-identified” referring to reproductive material derived from basic material which may be either a seed source or a stand located within a single region of provenance and which meets the requirements set out in Schedule III; (d) “tested” referring to reproductive material derived from basic material that shall consist of stands, seed orchards, parents of families, clones or clonal mixtures. The superiority of the reproductive material must have been demonstrated by comparative testing or an estimate of the superiority of the reproductive material calculated from the genetic evaluation of the components of the basic material. The material shall meet the requirements set out in Schedule VI; “marketing” refers to a display with a view to sale, offering for sale, sale or delivery to another person including delivery under a service contract; “official body” means the Department; “origin” in respect of an autochthonous stand or seed source, the origin is the place where the trees are growing. For a non- autochthonous stand or seed source, the origin is the place where the seeds or plants were originally introduced. The origin of a stand or seed source may be unknown; B 4664 “production” includes all stages in the generation of the seed unit, the conversion from seed unit to seed and the raising of planting stock from seeds and parts of plants; “provenance” refers to the place where any stand of trees is growing; “region of provenance” in respect of a species or sub-species, the region of provenance is the area or group of areas subject to sufficiently uniform ecological conditions in which stands or seed sources showing similar phenotypic or genetic characters are found, taking into account altitudinal boundaries where appropriate; “reproductive material” refers to any of the following: (a) seed unit which consists of cones, infructescenses, fruits and seeds intended for the production of planting stock; (b) parts of plants consisting of stem cuttings, leaf cuttings and root cuttings, explants or embryos for micropropagation, buds, layers, roots, scions, sets and any parts of a plant intended for the production of planting stock; (c) planting stock being plants raised from seed units, from parts of plants, or from plants from natural regeneration; “supplier” is any natural or legal person engaged professionally in the marketing or importation of forest reproductive material. 4. No person shall produce, place on the market in Malta or tranship through Malta prior to its transport to another Member State any propagation material unless this has been certified by the Director for any such purpose. 5. (1) Any person producing, placing on the market in Malta or transhipping through Malta prior to its transport to another Member State any propagation material shall notify the Director. (2) A notice submitted in accordance to subregulation (1) of this regulation shall be submitted on such form and in such manner and within such time as the Director may form time to time by notice in the Gazette, establish. 6. (1) Upon receipt of a notice in accordance with the provisions of regulation 5 hereof, the Director shall ascertain that the conditions Certification. Notification. General certification procedure. B 4665 for certification have been met and the Director shall issue such a certificate only if the propagation material meets such conditions or standards. (2) Prior to certifying any propagation material in accordance with subregulation (1) of this regulation, the Director or his authorised representative shall inspect, collect and test such sample or samples as may be required in order to establish that any provisions of these regulations are satisfied. (3) Any certificate issued in accordance with this regulation shall only be valid for the propagation material for which the inspection, sampling and testing were carried out in accordance with subregulation (2) hereof. 7. (1) Only approved basic material shall be utilised for the production of forest reproductive material that is to be marketed. (2) Basic material may be approved only by: (a) the Department if it meets the requirements set out in Schedules III, IV, V or VI hereto, as appropriate; or (b) reference to a unit known as the unit of approval. Each unit of approval shall be identified by a unique register reference. (3) The Department shall provide that: (a) approval shall be withdrawn if the requirements of these regulations are no longer met; and, (b) after approval, the basic material for the production of reproductive material under the “selected”, “qualified” and “tested” categories shall be re-inspected at regular intervals. (4) The Department may approve, for a maximum period of ten years, in all or part of Malta, basic material for the production of “tested” reproductive material where, from the provisional results of the genetic evaluation or comparative tests referred to in Schedules VI, it can be assumed that the basic material will, when tests have been completed, satisfy the requirements for approval under these regulations. (5) In the interest of conserving plant genetic resources used in forestry as stated in specific conditions established by the Department taking into account the developments in relation to the conservation in situ and the sustainable use of plant genetic resources through growing Approval of basic material. B 4666 and marketing of forestry reproductive material of origin that is naturally adapted to the local and regional conditions and threatened by genetic erosion, the Department may depart from the requirements laid down in subregulation (2) and in Schedules III, IV, V and VI, insofar as the specific conditions mentioned earlier in this subregulation are established. (6) The Department may restrict the approval of basic material intended for the production of forest reproductive material of the category “source-identified”. 8. If the basic material referred to in subregulation 7(1) is genetically-modified within the meaning of Directive 2001/18/EC of the European Parliament and of the European Council of the 12 th March, 2001, such material shall only be accepted if it safe for human health and the environment. Environmental risk assessments equivalent to that laid down in Directive 2001/18/EC should be carried out. 9. (1) The Department shall draw up a national register of the basic material of the various species approved in Malta. Full details of each unit of approval shall be recorded together with its unique register reference, in the national register. (2) A summary of the national register in the form of a national list shall be drawn up by the Department and shall be available on request to the European Commission and the other Member States. For the categories “source-identified” and “selected”, a summary of the units of approval within one region of provenance is permitted. The national list shall be presented for each unit of approval as referred to in paragraph 7(2)(b) and specified for each category of forest reproductive material mentioned in regulation 3. This list shall be drawn up in a standardised form as described in Schedule II hereof and shall be available as an electronic spreadsheet or database. The following details shall be provided: (a) botanical name; (b) category; (c) purpose; (d) type of basic material; (e) register reference or, where appropriate, summary thereof, or identity code for the region of provenance; Genetically- modified material. National Register of approved basic material. B 4667 (f) location: a short name, if appropriate, and any one of the following sets of particulars; (i) for the “source-identified” category: region of provenance and the latitudinal and longitudinal range; (ii) for the “selected” category: region of provenance and the geographical position defined by latitude and longitude and the latitudinal and longitudinal range; (iii) for the “qualified” category: the exact geographical position(s) where the basic material is maintained; (iv) for the “tested” category, the exact geographical position(s) where the basic material is maintained; (g) altitude or altitudinal range; (h) area: the size of a seed source(s), stand(s) or seed orchard(s); (i) origin: it shall be stated whether the basic material is autochthonous/indigenous, non-autochthonous/non-indigenous or if the origin is unknown. For non-autochthonous/non-indigenous basic material, the origin shall be stated if known; (j) in the case of material of the “tested” category, whether it is genetically-modified. 10. (1) During all stages of production, reproductive material shall be kept separate by reference from the individual units of approval. Each lot of reproductive material shall be identified by the following: (a) master certificate code and number; (b) botanical name; (c) category; (d) purpose; (e) type of basic material; (f) register reference or identity code for the region of provenance; Identification of reproductive material. B 4668 (g) region of provenance – for reproductive material of the “source- identified” and “selected” categories or other reproductive material if appropriate; (h) if appropriate, whether the origin of the material is autochthonous or indigenous, non-autochthonous or non- indigenous, or unknown; (i) in the case of seed units, the year of ripening; (j) age and type of planting stock of seedlings or cuttings, whether undercuts, transplants or containerised; and (k) whether it is genetically-modified. (2) Without prejudice to the provisions of subregulation (1) of this regulation and of paragraph 16(1)(c), the Department may provide for subsequent vegetative propagation of a single unit of approval in the “selected”, “qualified” and “tested” categories. In such cases, the material shall be kept separate and identified as such. (3) Without prejudice to the provisions of subregulation (1), the Department may provide: (a) within a single region of provenance, for mixing of reproductive material derived from two or more units of approval within the “source-identified” category or within the “selected” category; (b) when mixing of reproductive material, within a single region of provenance, from seed sources and stands in the “source- identified” category takes place, that the new combined lot will be certified as “reproductive material derived from a seed source”; (c) when mixing of reproductive material derived from non- autochthonous or non-indigenous basic material with reproductive material obtained from basic material of unknown origin takes place, that the new combined lot will be certified as being “of unknown origin”; (d) when mixing takes place in accordance with paragraphs (a) to (c) that the identity code for the region of provenance may be substituted for the register reference as in paragraph (1)(f) of this regulation; B 4669 (e) for mixing of reproductive material derived from a single unit of approval from different years of ripening; and (f) when mixing takes place in accordance with paragraph (e) that the actual years of ripening and proportion of material from each year shall be recorded. 11. In the case of basic material intended for the production of reproductive material of the “source-identified” and “selected” categories, the Department shall for the relevant species, demarcate the regions of provenance. Maps showing the demarcations of the regions of provenance shall be drawn up and published by the Department. These maps shall be sent to the European Commission and the other Member States. 12. (1) Reproductive material obtained from individual units of approval or lots shall remain clearly identifiable throughout the entire process from collection to delivery to the end user. Official inspections of registered suppliers shall be carried out regularly. Suppliers shall provide the Department with records, which shall contain details of all the consignments detained and marketed. (2) The Department shall take all the necessary measures to ensure compliance with the provisions of these regulations by making suitable arrangements for forest reproductive material to be officially controlled during production with a view to marketing and marketing. 13. Forest reproductive material shall, where applicable, comply with the relevant plant health conditions laid down in the Act. 14. (1) After harvesting, a master certificate showing the unique register reference shall be issued by the official body for all reproductive material derived from approved basic material, giving the relevant information set out in Schedule IX. (2) Where subsequent vegetative propagation is provided for in accordance with subregulation 10(2), a new master certificate shall be issued. (3) Where mixing takes place in accordance with sub- paragraphs (a), (b), (c) or (e) of subregulation 10(3), it shall be ensured that the register references of the components of the mixtures are identifiable and a new master certificate or other document identifying the mixture shall be issued. Control of reproductive material. Health of forest reproductive material. Master certificates. Regions of provenance. B 4670 15. Seed units shall be marketed only in sealed packages. The sealing device shall be such that it will become unserviceable when the package is opened. 16. (1) The following statements apply to the marketing of forest reproductive material derived from approved basic material: (a) material of the species listed in Schedule I shall not be marketed unless it is of the categories “source-identified”, “selected”, “qualified” or “tested”, and meets the requirements of Schedules III, IV, V and VI respectively; (b) material of the artificial hybrids listed in Schedule I shall not be marketed unless it is of the “selected”, “qualified” or “tested” categories and meets the requirements of Schedules IV, V and VI respectively; (c) material of the species and artificial hybrids listed in Schedule I which are reproduced vegetatively shall not be marketed unless it is of the “selected”, “qualified” or “tested” categories and meets the requirements of Schedules IV, V and VI respectively. In the case of reproductive material of the “selected” category, it may only be marketed if it has been mass propagated from seeds; (d) material of the species and artificial hybrids listed in Schedule I, which is wholly or partly genetically-modified, shall not be marketed unless it is of the “tested” category and meets the requirements of Schedule VI. (2) The categories under which reproductive material obtained from the different types of basic material may be marketed, are as set out in Table 1.5 of Schedule VII. (3) Forest reproductive material of the species and artificial hybrids listed in Schedule I shall not be marketed unless it meets the relevant requirements in Schedule VIII. Parts of plants and planting stock may not be marketed unless they meet the requirements of prevailing international standards, once those standards are approved in accordance with rules of the European Union. (4) Suppliers of forest reproductive material shall be officially registered. The official body may deem suppliers, who are already registered under the Act to be registered for the purposes of these regulations. Such suppliers shall nonetheless comply with the requirements of these regulations. Packaging of seed units. Marketing of basic material. [...]... document) giving, in addition to the information required under regulation 10, the following information: (a) master certificate number(s) issued under regulation 14 or reference to the other document available according to subregulation 14( 3); (b) name of supplier; (c) quantity supplied; (d) in the case of reproductive material of the “tested” category whose basic material is approved under subregulation... covered by this certificate the result of a subdivision of a larger lot covered by a previous EC certificate? Yes ) No ) Previous certificate number ………………………………… Quantity in initial lot …………………………………… 14 Length of time in nursery: ……………………………………………………………… …………………………………………………………… Yes ) 15 Has there been subsequent vegetative propagation of material derived from seed? No ) Method of propagation ………………... covered by this certificate the result of a subdivision of a larger lot covered by a previous EC certificate? Yes ) No ) Previous certificate number ……………………………… Quantity in initial lot …………………………….……… 14 Length of time in nursery: ………………………………………… ……….………… …………………………………………………………… 15 Number of components represented: Families: ………………………………….………… Clones: ……………………………………….……… 16 Altitude or altitudinal... covered by this certificate the result of a subdivision of a larger lot covered by a previous EC certificate? Yes ) No ) Previous certificate number ……………………………… Quantity in initial lot …………………………….……… 14 Length of time in nursery: ………………………………………… ……….………… 15 For clonal mixtures: Number of clones in the mixture: ……… Range of percentage composition of component clones: …………………………… 16 Other relevant information: . and commencement. Scope. Interpretation. Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,584, 14 ta’ Mejju, 2004 Taqsima B –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– B. the Forest Reproductive Material Regulations, 2004. (2) These regulations shall come in force on the 15th May, 2004. 2. (1) The scope of these regulations